WEGOVY

Orange BookUNIISPLATC A10BJ06

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeA10BJ06

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009058240
4 SYRINGE, PLASTIC in 1 CARTON (50090-5824-0) / .5 mL in 1 SYRINGE, PLASTIC

Annotations

UNII (FDA Substance ID)

53AXN4NNHX

SEMAGLUTIDE

RxCUI 1991302

Orange Book

N215256

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "53AXN4NNHX",
    "rxcui": "1991302",
    "inchikey": null,
    "display_name": "SEMAGLUTIDE",
    "substance_type": "protein",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "ee06186f-2aa3-4990-a760-757579d8f77b": {
      "match": "brand_token",
      "title": "WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION WEGOVY (SEMAGLUTIDE) TABLET [NOVO NORDISK PHARMACEUTICAL INDUSTRIES, LP]",
      "spl_version": "18",
      "published_date": "2026-05-22"
    }
  },
  "productid": "50090-5824_58b8887c-a572-4a74-ad0b-1049d388e206",
  "productndc": "50090-5824",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215256",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.25MG/0.5ML (0.25MG/0.5ML)",
        "product_no": "001",
        "approval_date": "Jun 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG/0.5ML (0.5MG/0.5ML)",
        "product_no": "002",
        "approval_date": "Jun 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1MG/0.5ML (1MG/0.5ML)",
        "product_no": "003",
        "approval_date": "Jun 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.7MG/0.75ML (1.7MG/0.75ML)",
        "product_no": "004",
        "approval_date": "Jun 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "2.4MG/0.75ML (2.4MG/0.75ML)",
        "product_no": "005",
        "approval_date": "Jun 4, 2021"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.2MG/0.75ML (7.2MG/0.75ML)",
        "product_no": "006",
        "approval_date": "Mar 19, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEMAGLUTIDE",
  "proprietary_name": "WEGOVY",
  "active_ingred_unit": "mg/.5mL",
  "application_number": "NDA215256",
  "marketing_category": "NDA",
  "nonproprietary_name": "semaglutide",
  "start_marketing_date": "20210605",
  "active_numerator_strength": ".25"
}

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